Allergic conjunctivitis
Conditions
Interventions
AGN-229666 0.25% (1 drop administered bilaterally at hour 0 of Visits 4 and 5)
vehicle (1 drop administered bilaterally at hour 0 of Visits 4 and 5)
olopatadine 0.1% (1 drop administered bilaterally a
Sponsors
Senju Pharmaceutical Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Be a male or female, at least 20 years of age 2) Be a Japanese patient living in Japan 3) Have the ability to follow study instructions and likely to complete all required Visits 4) Females of childbearing potential must have a negative urine pregnancy test and must not be breastfeeding. 5) Have a history of allergic conjunctivitis and a positive skin test reaction to Japanese cedar pollen-specific allergen 6) Have best-corrected visual acuity of 0.2 or better, using the landolt ring chart 7) Have a positive bilateral CAC reaction at Visit 2 8) Have a positive bilateral CAC reaction at Visit 3 9) Be willing to discontinue wearing any contact lenses 10) Provide written informed consent
Exclusion criteria
Exclusion criteria: 1) Have a history of allergic hypersensitivity to any compound or chemical class related to the investigational drug being studied or its excipients used in this trial 2) Have previous participation in a clinical trial with AGN-229666 3) Have presence of any ocular condition that could affect the patient's safety or trial parameters 4) Have known history of vernal keratoconjunctivitis and/or atopic keratoconjunctivitis 5) Have had ocular surgical intervention and/or a history of refractive surgery 6) Have a known history of retinal detachment, diabetic retinopathy, or progressive retinal disease 7) Have the presence of an active ocular infection or preauricular lymphadenopathy, or positive history of an ocular herpetic infection 8) Have any uncontrolled systemic disease 9) Have history of status asthmaticus, persistent moderate or severe asthma, or moderate to severe allergic asthmatic reactions to study allergen(s) 10) Manifest signs or symptoms of clinically active allergic conjunctivitis 11) Be a female who is pregnant or nursing, or a person who is planning a pregnancy 12) Be a person not using a reliable means of contraception 13) Have a use of disallowed medications during the appropriate pre-study washout period or anticipated use during the study 14) Have a use of depot corticosteroids within 6 months or anticipated use during the study 15) Have planned surgery (ocular or systemic) during the study period or within 30 days after completion 16) Be currently enrolled in an investigational drug or device study or have had administration of investigational drug in such a study within 16 weeks of entry into this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ocular itching | — |
Countries
Japan
Contacts
Public ContactTakuro Sekiya
Senju Pharmaceutical Co.,Ltd. Clinical Development
Outcome results
None listed